International, multicenter, randomized, non-comparative controlled study of therapeutic intensification plus immunomodulation in HIV patients with long-term viral suppression - ERAMUNE-01
- Conditions
- HIV-1 InfectionMedDRA version: 14.1 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2009-014406-34-GB
- Lead Sponsor
- ORVACS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
- HIV-1 infection, documented by any licensed ELISA test kit and confirmed by Western Blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test - 18 = Age = 70 years - At least 3 years of suppressive ART without any interruption (less than one month cumulative), - ART treatment unchanged in the 3 months prior to screening - One HIV plasma viral load (RNA) documented at least 3 years prior to entry, and at least 2 HIV plasma viral loads (RNA) documented per year thereafter - HIV plasma viral load (RNA) = 500 copies/ml at least 3 years prior to entry and HIV plasma viral load = 500 copies/ml for 90% of the measures thereafter - HIV plasma viral load (RNA) below the limit of detection for all values within the past year. Note: the assay used must have a lower limit of detection of 75 copies/ml or less - CD4+ count = 350 cells/mm3 within 60 days of entry - 10 = Proviral DNA = 1000 copies/106 PBMCs within 60 days of entry - Documented laboratory values: Haemoglobin = 10 g/dl, Platelets = 100,000 per microliter, Hepatic transaminases = 2.5 x ULN, Creatinine clearance = 50 ml/min by the Cockcroft –Gault equation - All subjects must agree not to participate in the conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable forms of contraceptives (condoms, with or without spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, or hormone-based contraception), while receiving study treatment and for 6 weeks after stopping study treatment - Ability and willingness to provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
- Sexually active men and women who will not practice at least one form of barrier birth control (male partner using condoms, female partner using condoms, other barrier contraception, etc) - Pregnancy as documented by a urine pregnancy test, or lactating women - Hepatitis B antigen (HBsAg) positive - Hepatitis C virus (HCV-Ab) positive or HCV RNA detectable - Previous use of an integrase inhibitor (ie raltegravir) or a CCR5 inhibitor (ie maraviroc, vicriviroc). Use of Raltegravir for non-treatment failure indications such as intensification and toxicity switches is allowed, provided that 1) virologic suppression was maintained before, during and after raltegravir treatment and 2) the patient has not received raltegravir treatment in the 6 months prior to the study entry. - Previous immunologic therapeutic intervention (e.g. IL-2, IL-7) within the past year - Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted - Diagnosis of cancer within the last 5 years (except basal cell cutaneous cancers and cutaneous KS not requiring systemic therapy - Co-morbid condition with an expected survival less than 12 months - History of hypersensitivity to vaccination - History of autoimmune disease, such as systemic lupus erythematosis (SLE) or Hashimoto’s thyroiditis - Active drug or alcohol use or dependence that, in the opinion of the center investigator, would interfere with adherence to study requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method